Psoriasis
Conditions
Brief summary
Add-on Enstilar to Otezla therapy.
Detailed description
50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 16 weeks with add-on Enstilar.
Interventions
DRUGOtezla
Otezla 30mg BID
Sponsors
Celgene Corporation
Psoriasis Treatment Center of Central New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female adult ≥ 18 years of age; 2. Diagnosis of chronic plaque-type psoriasis 3. Moderate to severe plaque type psoriasis as defined at baseline by: * PGA score of 3 or greater * BSA affected by plaque-type psoriasis of 10% or greater * PASI ≥ 12 4. Able and willing to give written informed consent prior to performance of any study-related procedures 5. Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
Exclusion criteria
1. Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled. 2. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis 3. Subjects who previously used any biologic agent for psoriasis. 4. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine). 5. Patient used topical therapies to treat psoriasis on the hands and/or feet within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids). 6. Patient received UVB phototherapy within 2 weeks of Baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area Severity Index 75 at Week 12 | 12 weeks | Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Otezla Enstilar Otezla 30mg BID Enstilar QD | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Otezla Enstilar |
|---|---|
| Age, Continuous | 48 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 7 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
Primary
Psoriasis Area Severity Index 75 at Week 12
Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Otezla Enstilar | Psoriasis Area Severity Index 75 at Week 12 | 29 Participants |